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news.United Therapeutics Europe has received marketing authorisation from the European Medicines Agency (EMA) for Unituxin (dinutuximab) to treat high-risk neuroblastoma, a type of cancer that most often occurs in young children.
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Unituxin, a monoclonal antibody, is intended for use in children who have responded to an induction treatment with chemotherapy, followed by myeloablative therapy and autologous stem-cell transplantation.
Neuroblastoma forms from immature nerve cells and is usually seen as a lump in the abdomen or around the spine and typically occurs in children under five years of age.
Unituxin has been designed to recognise and attach to a specific structure (an antigen) called disialoganglioside (GD2), which is present in high amounts on the surface of neuroblastoma cells, but in lower amounts in normal cells.
The company has evaluated the safety and efficacy of Unituxin in a clinical trial in children with high-risk neuroblastoma who had already responded to chemotherapy and were further treated with myeloablative therapy and autologous stem-cell transplantation.
A total of 230 patients were included in the trial and they were given Unituxin combined with other immunotherapy (GM-CSF and IL-2) and an oral retinoid medicine (isotretinoin) or isotretinoin alone.